Benzinga | Dec 15, 2021 01:55PM EST

Eagle Pharma Reports Received FDA Approval For Vasopressin

Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's abbreviated new drug application ("ANDA") for vasopressin. This approval follows the recent U.S. District Court for the District of Delaware decision holding that Eagle's proposed vasopressin product does not infringe any of the patents Par Pharmaceutical, Inc. et al. asserted against the Company.

"We expect vasopressin to be a significant addition to our hospital and critical care portfolio, and we are delighted to now have final FDA approval for our A-rated, therapeutic equivalent product. We also anticipate 180-day marketing exclusivity. This is an important product for us, and a much-needed generic alternative to Vasostrict(r) for providers and patients. We are implementing our launch plans to bring vasopressin to market," stated Scott Tarriff, President and Chief Executive Officer of Eagle.